Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00163852
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Bayside Health
• Public title: Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
• Scientific title: Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
• Date of first enrolment: February 2004
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00163852
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia

Contacts

• Name: Alan C Young, MBBS, FRACP

• Name: Matthew T Naughton, MBBS, MD
• Affiliation: The Alfred

• Name: Alan C Young, MBBS

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult cystic fibrosis patient

- Admission with acute exacerbation (criteria- fall in FEV1 > 10% from best in last
12/12, change in sputum volume and colour, new pulmonary infiltrate)

- PaCO2 > 45 mmHg on admission

- Primary metabolic alkalosis (acid-base diagram of Stinebaugh and Austin)

- Serum chloride (Cl) = 98 mmol/L

- Serum albumin (alb) = 25 mmol/L

Exclusion Criteria:

Concurrent diuretic therapy Concurrent glucocorticoid therapy



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Normal saline IV, salt tablets

Primary Outcome(s)

•Acid-base status (Stinebaugh and Austin, ABG’s)

•Overnight oximetry (% night SpO2<90%) and PtcCO2 (rise in CO2 overnight)

Primary outcome measures: (Day1, D4, D10)

•PaCO2 (performed at same time of day as admission ABG’s)

•Serum chloride

Secondary Outcome(s)

•Spirometry (D1, D10)

•Urinary chloride, potassium, sodium, pH, osmolality

•Body mass index (BMI)

•Epworth sleepiness scale

•Wrist actigraphy (circadian rhythm and daytime activity level)(D1-10)

•Headache scale

•Serum albumin, sodium

•Baseline ABG’s as stable outpatient (within 3 months, pre or post admission)

Secondary outcome measures: (Day1, D4, D10)

Secondary ID(s)

14/04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Monash University

Cystic Fibrosis Australia

National Health and Medical Research Council, Australia